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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Recombinant Technology
510(k) Number K122487
Device Name BIOFIBER SYTURE
Applicant
Tornier, Inc.
10801 Nesbitt Ave.
Bloomington,  MN  55437
Applicant Contact LAEL J PICKETT
Correspondent
Tornier, Inc.
10801 Nesbitt Ave.
Bloomington,  MN  55437
Correspondent Contact LAEL J PICKETT
Regulation Number878.4494
Classification Product Code
NWJ  
Date Received08/15/2012
Decision Date 09/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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